Breakthrough: FDA Approves Taiho’s Lonsurf for Treatment of Metastatic Colorectal Cancer, Outpacing Takeda and Hutchmed!

The FDA has given the green light to Taiho Oncology’s Lonsurf (tipiracil) to be used in tandem with Roche’s Avastin (bevacizumab) as an effective treatment for metastatic colorectal cancer! This dynamic duo of medications promises to bring hope to those suffering with this devastating condition.

Lonsurf was launched in September 2015 with approval for use as the first monotherapy to treat patients with metastatic colorectal cancer. This week, the drug gained an expansion of its label, encompassing those previously treated with biologic agents, plus fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapies. It’s a major step forward in the battle against the disease.

The exciting news is that patients with the commonly found wild-type RAS protein, who had already taken an anti-EGFR therapy, can now benefit from the new combination regimen approved by the authorities.

Marwan Fakih, lead investigator of the SUNLIGHT trial, expressed his confidence that Lonsurf’s latest approval will revolutionize the treatment landscape for patients with mCRC. He said, “This new treatment option not only extends life, but also brings other benefits, strengthening the outlook of hope for such patients.”

The SUNLIGHT trial, a Phase III, randomized, open-label and global trial, proved to be pivotal in the FDA’s decision to approve the combination of Lonsurf and trifluridine/tipiracil as an effective therapy for Advanced Metastatic Colorectal Cancer.

This treatment was found to significantly reduce the risk of dying from any cause by 39% compared to Lonsurf monotherapy, as well as increasing progression-free survival. An incredible result that is sure to make a tremendous difference to the long-term health of patients.

The Lonsurf-Avastin combination demonstrated a remarkable ability to slow the progression of functional decline. Patients on the set regimen witnessed a median delay of 9.3 months, from when their ECOG performance status deteriorated from a score of 0 to 1 to 2 or above. This was almost three months longer than those treated with Lonsurf monotherapy, who saw a similar decline in 6.3 months. The results are truly remarkable.

The combination regimen proved to have a safe and manageable adverse event profile. Patients displayed a common severe response to its treatment which was neutropenia.

Taiho Pharmaceutical Co. recently received a major victory in the field of cancer research. On Wednesday, the company was given approval to market its cancer drug fruquintinib to treat patients with metastatic colorectal cancer. This approval puts Taiho ahead of Takeda and Hutchmed, another Hong Kong-based collaborator, who are both working on fruquintinib and had applied for its approval with the FDA.

The FDA granted the application a Priority Review, and it is expected to make its decision by the end of November. With this approval, Taiho has taken a major step in changing the lives of those suffering from this type of cancer.

In January 2023, Takeda made a big move to secure the future of Hutchmed’s newly-discovered candidate, fruquintinib, splashing out $400 million upfront and committing to pay a further $730 million for exclusive worldwide rights outside the greater China region. This huge investment signals Takeda’s faith in the potential of fruquintinib.

Fruquintinib, believed to be a promising treatment for gastric cancer, is currently being tested by Takeda and Hutchmed as a second-line therapy. This comes shortly after Lonsurf received FDA approval for the same indication back in February 2019.

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